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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| United States Department of Defense | FED |
The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.
It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.
In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pemetrexed plus cisplatin, vinorelbine and docetaxel | Experimental | This is a phase 2 clinical trial for patients with clinical Stage IB-III resectable and operable non-small cell lung cancer, evaluating whether the switch to an alternative, non-platinum neoadjuvant chemotherapy is safe and effective in patients who do not respond to neoadjuvant platinum-based chemotherapy. Those who fail to respond to platinum-based chemotherapy will be switched to the alternative neoadjuvant chemotherapy vinorelbine 45 mg/m2 and docetaxel 45 mg/m2 on day 1 followed by pegylated filgrastim on day 2, repeated every 2 weeks for 4 doses, followed by repeat FDG PET and CT scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| PERCIST Partial Metabolic Response | The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Response Rate | The percentage of patients with a major pathologic response | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie E. Chaft, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan-Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Carboplatin | Drug |
|
| Gemcitabine Hydrochloride | Drug |
|
| Vinorelbine Tartrate | Drug |
|
| Docetaxel | Drug |
|
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PERCIST Partial Metabolic Response | The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline). | Posted | Number | participants | 2 years |
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| Secondary | Pathologic Response Rate | The percentage of patients with a major pathologic response | Posted | Number | 95% Confidence Interval | percentage of patients | 2 years |
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There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer | 4 | 42 | 34 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal infection | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
| |
| Dyspnea | General disorders | CTC-4.0 | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | CTC-4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTC-4.0 | Systematic Assessment |
| |
| Thromboembolic event | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
| |
| White blood cell decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTC-4.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Anemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC-4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chaft, Jamie, MD | Memorial Sloan Kettering Cancer Center | 646-888-4545 | ChaftJ@mskcc.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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